Recruiting

Heat Stress

Sponsor:

Providence College

Code:

NCT07036640

Conditions

Lactation

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Heat exposure

Study Details

Brief summary:

This clinical trial aims to determine whether heat stress alters 24-hour breast milk production and composition following an acute bout of exercise in the heat among lactating women.

The main questions are:

1. To ascertain whether heat stress alters 24-hour breast milk production following acute exercise in the heat among lactating women. We hypothesize that breast milk production will decrease to a greater extent following acute exercise in the heat compared to acute exercise with no heat stress. Lactating mothers will complete an acute exercise bout at 40% of their peak oxygen consumption (VO2peak) for 60 mins in a hot (36 °C, 40% relative humidity) and thermoneutral environment (20 °C, 20% relative humidity). Participants will record their total breast milk production in a 24-hour period using an infant scale.
2. to discover whether heat stress impacts the energy composition of breast milk following acute exercise in the heat among lactating women. We hypothesize that energy density will decrease to a greater extent following acute exercise in the heat compared to acute exercise with no heat stress. Participants will use a manual expression breast pump to collect 10 mL of breast milk from each breast immediately and 24 hours post-exercise. Energy density (lactose, protein, and lipid content) will be assessed via enzyme-linked immunosorbent assays.

Participants will complete the following visits: 1) initial consent visit 2) baseline testing; 3) acute exercise in the hot condition (HOT; 36C, 40% relative humidity), and 4) acute exercise in the temperate, thermoneutral condition (TEMP; 20C, 20% relative humidity). The baseline testing day will measure participant anthropometrics including height, weight, and body composition measured by a DEXA scan. For both experimental trials, participants will be asked to walk on a treadmill at based on their metabolic heat production (8W/kg) for 60 minutes. Heart rate (HR), mean skin temperature (Tsk), core temperature (Tcore), sweat loss (SL), and fluid intake will be measured throughout the exercise protocol. Breast milk composition will be measured through milk expression using a manual expression breast pump immediately and 24 hours post-exercise. Participants will log their breast milk production for 24 hours following the exercise using an infant scale to measure their infants before and after each feed.

Conditions

Lactation

Study ID

NCT07036640

Start date

Jul 10, 2025

Status verified date

Jun, 2025

Completion date

May 1, 2026

Anticipated

Primary completion date

May 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Currently breastfeeding or pumping expressed breastmilk for their 6-week to 24-month infants
  • Aged 18-45 years old
  • Delivered their infants between 37-42 weeks of gestational age

Exclusion Criteria:

  • Obsterical complications during pregnancy
  • multiple gestation
  • Chronic disease (i.e., diabetes, hypertension, metabolic disease)
  • Heat illnness in the last 3 month

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Heat exposure

Heat exposure in environmental chamber during exercise (60 mins)

no intervention: Thermoneutral Condition

Thermoneutral temperature (non-heat exposure condition)

Interventions

Heat exposure

Heat exposure during exercise

Primary outcome measure

  • Breastmilk Composition [ Time Frame: Measured 24hr before exercise, one hour post-exercise, and 24hr post exercise for each condition ]
  • Breastmilk Production [ Time Frame: Collected 24-hour before exercise, 1-hour post-exercise, and 24-hour post-exercise ]

Central Contacts and Locations

Central contacts

Margaret C Morrissey-Basler, PhD

4018650219mmorri17@providence.edu

Locations

Providence College

Recruiting

Providence, Rhode Island, United States, 02918

Contacts

Margaret C Morrissey-Basler, PhD

4018650219mmorri17@providence.edu

More Information

Sponsor

Providence College

Last update posted

Jun 25, 2025

Last verified

Jun, 2025

Keywords

  • Lactation
  • Exercise
  • Heat Stress

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Providence College on 2025-06-25.